Recalled applesauce may have been contaminated intentionally, FDA says

The Food and Drug Administration said a theory it is investigating is that the recalled applesauce products were intentionally contaminated with high levels of lead.

The Food and Drug Administration (FDA) is exploring the possibility that recalled applesauce products could have been intentionally contaminated with high levels of lead. 

"The FDA can confirm that one of the theories the agency is exploring regarding the high lead levels in the recalled cinnamon applesauce pouches is the potential that the cinnamon contamination occurred as a possible result of economically motivated adulteration," an FDA spokesperson told FOX Business said in a statement. 

However, given that the investigation is still ongoing, the agency reiterated that this is only one theory it is exploring, and that "additional investigation needs to occur before FDA reaches any conclusions." 

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WanaBana, Schnucks, or Weis-brand apple cinnamon pouches — manufactured by Ecuador-based Austrofood — were recalled in November for elevated lead levels as lead poisoning cases started to increase across the country. 

The FDA and Centers for Disease Control and Prevention (CDC) as well as state and local partners are currently investigating reports of elevated blood lead levels in people who consumed the Apple Cinnamon Fruit Puree pouches.

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As of Dec. 11, the FDA received 65 reports of adverse events potentially linked to the recalled product. The confirmed complainants, or people for whom an adverse event was submitted, are all under 6 years old, the FDA said. 

Separately, the CDC reported that it has received over 200 reports of cases from state and local health departments nationwide.

The FDA said samples of cinnamon supplied by Negasmart to Austrofoods revealed "extremely high levels of lead contamination of about 5110 parts per million (ppm) and 2270 ppm." 

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For context, the FDA said the Codex Alimentarius Commission — an international food standards body established jointly by the Food and Agriculture Organization and the World Health Organization — is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024.

The FDA said it is "relying on officials in Ecuador to support the investigation into Negasmart." 

However, the agency has confirmed that the company doesn't ship product directly to the U.S. Only Austrofoods, one of Negasmart’s direct customers, ships product to the U.S.

The FDA told FOX Business that it will continue to keep the public updated as the investigation unfolds.